AACR Project Genomics Evidence Neoplasia Information Exchange (GENIE) is a multi-phase, multi-year, national and international project that catalyzes precision oncology through the development of a regulatory-grade registry aggregating and linking clinical-grade cancer genomic data with clinical outcomes from tens of thousands of cancer patients treated at participating institutions.

AACR Project GENIE fulfills an unmet need in oncology by providing the statistical power necessary to improve clinical decision-making, particularly in the case of rare cancers and rare variants in common cancers. Additionally, the
registry can power novel clinical and translational research.

The data within GENIE are shared with the global research community after defined periods of time through cBioPortal and the Synapse Platform. The project serves as a prototype for aggregating, harmonizing, and sharing clinical-grade, next-generation sequencing data obtained during routine medical practice.

GENIE is Unique

The registry contains the existing CLIA-/ISO-certified genomic data obtained during the course of routine practice at multiple national and international institutions, and will continue to grow as more patients are treated at the participating centers and as new centers join the project. As a result, the registry is derived from a variety of cancer types, including rare cancers, and is enriched in examples of late-stage disease; thus it approximates more of a “real world” dataset.

One Registry, Many Uses

* Powering clinical and translational research

The database can be used to generate many research hypotheses spanning translational to clinical studies, including those that would inform new or ongoing clinical trials.

* Validating biomarkers

* Drug repositioning/repurposing*

* Adding new mutations to existing drug labels*

* Identifying new drug targets

* Could provide the evidence base necessary to support reimbursement for next-generation sequence-based testing by payers.

* The AACR will be working closely with the FDA to ensure that the registry contains data that could be accepted as evidence supporting regulatory approval.

Support

Recognizing the need, urgency, and timeliness of such a project, the AACR provided the seed money for the first phase.